MAUDE Adverse Event Report: BIOMET 3I; DENTAL ABUTMENT

Device Problem Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/05/2022

Event Type  malfunction  

Manufacturer Narrative

Multiple mdr reports were filed for this event.Please see associated report: 0001038806-2022-01857 zimmerbiomet complaint number (b)(4).No device catalog or lot number was provided so a device history record review and a complaint history review could not be performed.Since the device will not be returned, identifying a definitive root cause will not be possible.Should additional information be received which identifies the product or indicates that the device may have caused or contributed to the event, an additional report will be submitted h3 other text : device is not being returned.

Event Description

It was reported that the healing abutment became loosened on implant #7 and had to be removed.

Event Description

Upon follow up with the customer, this event occurred on a different date therefore, a new complaint was opened and processed for this event.Therefore, this report is being submitted as a retraction as the initial report, mfr: 0001038806-2022-01861 is a duplicate of mfr: 001038806-2022-01879.For all details and information regarding this event, please see mfr: 0001038806-2022-01879.

Manufacturer Narrative

This report is being submitted to relay corrected data.Corrected data: this report is being submitted as a retraction as the initial report, mfr: 0001038806-2022-01861 is a duplicate of mfr: 001038806-2022-01879.For all details regarding this event.Please see report: mfr: 001038806-2022-01879.

• Type of Device: DENTAL ABUTMENT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 15939258
• MDR Text Key: 306031023
• Report Number: 0001038806-2022-01861
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/14/2022
• Initial Date FDA Received: 12/08/2022
• Supplement Dates Manufacturer Received: 12/09/2022
• Supplement Dates FDA Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DENTAL IMPLANT.
• Patient Sex: Male